Status:
NOT_YET_RECRUITING
Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects
Lead Sponsor:
SIPO Biotechnology Co. Ltd.
Collaborating Sponsors:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Skin Aging
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.
Detailed Description
SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded by Extracellular vesicles （EVs）) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation...
Eligibility Criteria
Inclusion
- Aged 18 to 75 years inclusive at the time of informed consent.
Exclusion
- Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
- History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
- History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
- Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
- Pregnant or breast-feeding females.
- History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
- Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
- Those who are not suitable for subcutaneous injection and biopsy.
- Any condition that the investigator or primary physician believes may not be appropriate for participating the study.
Key Trial Info
Start Date :
November 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06567119
Start Date
November 12 2025
End Date
December 15 2027
Last Update
May 15 2025
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